MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. ARTIC-L¿ AND ARTIC-XL¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	5330008
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a device used for spinal therapy.It was reported that the inserter experienced instrument breakage when the inserter broke and the pins in the inserters were backing out.The loose piece was identified before use, and no patient was involved.No patient complications have been reported as a result of this event.Additional information was received from the manufacturer representative that for the first inserter also, the pin was backing out making grip handle loose.
Additional Manufacturer Narrative
H3: product analysis : product# 5330008; lot # cn17g006 visual and optical inspection confirmed the laser weld on one side of the handle has broken.The damage appears to be from overload placed on the instrument during use medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ARTIC-L¿ AND ARTIC-XL¿ SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23590138
• Report Number: 3003120897-2025-00590
• Device Sequence Number: 21313353
• Product Code: MAX
• UDI-Device Identifier: 00763000085902
• UDI-Public: (01)00763000085902(11)190731(10)CN17G006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5330008
• Device Catalogue Number: 5330008
• Device Lot Number: CN17G006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown